Wheelchair User Physical Activity Training Intervention to Enhance Cardiometabolic Health

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06013046
Status
Recruiting
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Conditions

  • Physical Disability

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intensity-controlled physical activity training (IPAT) — BEHAVIORAL
    The IPAT group will receive 40 (90 minute) one-on-one, intensity-controlled, exercise sessions by trained staff over 14 weeks. The initial 2-week period will include dedicated education on topics including physical activity guidelines and the benefits of achieving them, the feeling of moderate-to-vigorous physical activity intensity levels, and the appropriate exercises for achieving desired intensity levels. Tailored sessions will be created for each participant based on their physical fitness, goals, preferred exercise equipment and results from their baseline assessment. Each session can include vitals, pain assessment, warm-up, aerobic training, strength exercises and a cool-down. The participants will be monitored to ensure they are achieving at least 150 minutes of moderate-to-vigorous intensity physical activity weekly. Heart rate and actigraphy monitors will be worn during sessions to capture exercise intensity data. The overall goal is to improve cardiorespiratory fitness.
  • Education and Access (EA) — BEHAVIORAL
    The EA group will receive an initial 60 minute educational session, during which they will receive information on the adapted exercise equipment in the Orthwein Center, education on the physical activity guidelines and the health benefits of achieving them, and access to the Orthwein Center accessible gym. They will then complete a 14-week independent workout program with the goal of meeting physical activities guidelines. They will have access to Orthwein Center staff to help with minimal setup and guidance, but sessions will be self-directed. Heart rate and actigraphy monitors will be worn during sessions to capture exercise intensity data. Participants will be asked to complete a log for each session to report pain, details of the activities they completed during their workout, the RPE for each activity, and how long each activity lasted.

Study Details

The goal of the study is to improve cardiometabolic health outcomes for wheelchair users and identify strategies for achieving sufficient physical activity intensity during bouts of structured physical activity.

Key Dates

Start date
Aug 10, 2023
Status verified
Jan 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intensity-controlled physical activity training (IPAT)
    A group provided education on physical activity recommendations for people with disabilities, access to a community-based accessible gym, and an intensity-controlled 14-week one-on-one supervised physical activity training intervention.
  • Placebo Comparator: Education and Access (EA)
    A group provided education on physical activity recommendations for people with disabilities and access to a community-based accessible gym in order to independently complete a 14-week physical activity program.

Primary Outcome Measure

VO2max - Cardiorespiratory Fitness change (Max Oxygen Consumption Change in ml/kg/min) [ Time Frame: Baseline and up to 3 weeks post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63108
Kimberly A Walker, OTD
[email protected]
314-273-7010
Kerri A Morgan, PhD
[email protected]
314-286-1659

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By research site
Washington University School of Medicine· St Louis, MO

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